Illumina MiSeq i100 System or equal

The Food and Drug Administration Office of Acquisition and Grant Services has issued a Notice of Intent to Sole Source for the procurement of one Whole Genome Sequencing instrument. This special notice, posted on March 20, 2026, is intended for informational and market research purposes and does not constitute a formal solicitation. The FDA is considering the Illumina MiSeq i100 System or an equivalent product that meets all salient characteristics outlined in the Statement of Work. Interested parties are invited to submit capability statements demonstrating their ability to meet the specified requirements. The contracting officer for this procurement is Iris Johnson, who can be reached at Iris.Johnson1@fda.hhs.gov.

The instrument will support microbiological testing and sequencing of microorganisms from regulatory pharmaceutical samples at the FDA's Irvine Medical Products Laboratory to ensure compliance with USP and other regulatory requirements. Offerors proposing equivalent products must clearly demonstrate how their offerings meet each salient characteristic, including sequencing-by-synthesis next-generation sequencing technology, output specifications of up to 25 Gigabases with up to 200 million paired-end reads per run, and maximum read lengths of at least 2,500 base pairs. The selected contractor must deliver the instrument within 60 days of award to the facility in Irvine, California, and provide a minimum one-year manufacturer's warranty covering parts, labor, and operational support. Capability statements must be submitted by March 26, 2026, at 2:30 PM Eastern Time. While there are no specific set-asides for disadvantaged businesses or other categories, all contractors meeting the technical specifications are eligible to submit responses.